Palladone

   
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Palladone


Drug - Palladone
The trade name of the product as shown on the labeling.

Dosage - CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Hydromorphone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 16MG
The potency of the active ingredient(s), Hydromorphone Hydrochloride. May repeat for multiple part products.

Applicant - PURDUE PHARMA LP
The firm name holding legal responsibility for Palladone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021044
The FDA assigned number to Palladone. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Palladone. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 24, 2004
The date Palladone was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Palladone. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Palladone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Purdue Pharma Lp
The full name of the firm holding legal responsibility for the new application of Palladone.

Palladone